REGULATORY SUPPORT FOR LEAD GENE THERAPY CANDIDATES AS A TREATMENT FOR ORGANIC ACIDEMIAS, PROPIONIC ACIDEMIA (PA) AND METHYLMALONIC ACIDEMIA TYPE B (MMAB)

NIH RePORTER · NIH · N02 · $46,977 · view on reporter.nih.gov ↗

Abstract

The scope of this task order is for the regulatory strategy, planning, preparation, submission and maintenance of meeting requests and application packages (such as INTERACT meeting, pre-IND meeting, IND submission and maintenance) to the FDA to support the lead candidates for gene therapy treatments.

Key facts

NIH application ID: 11088092
Project number: 75N95022D00014-P00002-759502200001-1
Recipient: —
Principal Investigator: —
Activity code: N02
Funding institute: NIH
Fiscal year: 2024
Award amount: $46,977
Award type: —
Project period: 2022-09-22 → 2025-09-21